Working with a competent clinical study site to perform an IVD clinical trial is a key factor for trial success and outcomes. Although IVD clinical studies share several commonalities with medical device trials, there are many differences and nuances that must be considered prior to selection of an adequate study site.
Join NAMSA for this upcoming webinar to explore the key differences between medical device and IVD clinical trials, and learn the key elements that should be explored and identified before finalizing study site(s) selection.
Webinar participants will leave with a better understanding of:
- Different site qualifications and selection processes for IVD and medical device trials
- Contracting, budgeting and cost considerations
- Lab certifications (CLIA, CAP)
- Principal Investigator and study staff qualifications and proficiencies (Good Clinical Practice and Regulatory Requirements)
- Methods of recruiting and accessing the desired study population
- How to assess competing and conflicting studies with the same targeted population
- On-site and remote monitoring
Time will also be allotted for Q&A.
Stacey HausmannPrincipal Clinical Research Associate
Stacey Hausmann has over 20 years of IVD product development experience, with a strong proficiency in immunoassays. She has established and managed clinical research sites, as well as managed and monitored IVD clinical studies. Prior to NAMSA, Stacey worked with Beckman Coulter where she gained experience in both instrument and reagent quality control as a technician, scientist and supervisor in each area. Stacey actively maintains her medical technician license and is a member of the American Society of Clinical Pathologists (ASCP).
Carlie LeydeSenior Clinical Trial Administrator
Carlie Leyde has over 6 years of Clinical Research experience with a focus in Pharma, Humanitarian Use Device and IVD. She has extensive experience organizing, maintaining and tracking site files, supporting internal and external audits, creating study materials and developing processes. Prior to NAMSA, Carlie worked at HealthPartners as a Neuroscience Research Coordinator. She has also worked at Minnesota Gastroenterology as a Clinical Research Coordinator and Regulatory Coordinator, and at Medtronic as a Clinical Research Specialist. Carlie holds a Bachelor’s degree in Mass Communications and is a Certified Clinical Research Coordinator with ACRP.